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Tegsedi Approval History

FDA Approved: Yes (First approved October 5, 2018)
Brand name: Tegsedi
Generic name: inotersen
Dosage form: Injection
Company: Ionis Pharmaceuticals, Inc.
Treatment for: Amyloidogenic Transthyretin Amyloidosis

Tegsedi (inotersen) is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Development History and FDA Approval Process for Tegsedi

DateArticle
Oct  5, 2018Approval FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
Jan  8, 2018Ionis' Inotersen NDA Accepted for Priority Review by the FDA

Further information

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